NESP Pediatric Study
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00527137
First received: September 6, 2007
Last updated: May 6, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period. During the study, procedures include bloodwork for laboratory assessments and vital signs. Dose titration determined by hemoglobin values taken weekly during the study. Antibody samples taken at baseline and during the end of study assessments. A physical examination and laboratory tests will conclude the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Pre-dialysis End Stage Renal Disease |
Drug: darbepoetin alfa Drug: rHuEPO |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Randomized, Non-inferiority Study of Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (rHuEPO) for the Treatment of Anemia in Pediatric Subjects With Chronic Renal Insufficiency (CRI) or End-stage Renal Disease (ESRD) Receiving Dialysis |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2000 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: rHuEPO |
Drug: rHuEPO
same as previous rHuEPO dose at randomization; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
|
| Experimental: darbepoetin alfa |
Drug: darbepoetin alfa
Dose 100U rHuEPO = 0.42 mcg NESP; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
|
Eligibility| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 1 to 18 years of age
- ESRD receiving dialysis or CRI with eGFR less than 30 mL/min
- Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete
- Stable rHuEPO therapy for 8 weeks
Exclusion Criteria:
- Scheduled for a living-related kidney transplant
- Uncontrolled blood pressure
- seizure activity
- Hyperparathyroidism
- Major surgery within 12 weeks or active inflammatory disease
- Currently receiving antibiotics
- Clinical evidence of malignancy
- Pregnant or breast-feeding
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00527137 History of Changes |
| Other Study ID Numbers: | 20000100 |
| Study First Received: | September 6, 2007 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Darbepoetin alfa |
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013